Elecsys Estradiol III MODULAR ANALYTICS E170 cobas e 411 06656021119 06656021500 100 cobas e 601 English cobas e 602 System information For cobas e 411 analyzer: test number 1370 R1 Anti‑estradiol‑Ab~biotin (gray cap), 1 bottle, 9 mL: For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Two biotinylated monoclonal anti‑estradiol antibodies (rabbit) Application Code Number 223 2.5 ng/mL and 4.5 ng/mL; mesterolone 130 ng/mL; MESb) buffer Intended use 50 mmol/L, pH 6.0; preservative. Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. R2 Estradiol‑peptide~Ru(bpy) (black cap), 1 bottle, 9 mL: The electrochemiluminescence immunoassay “ECLIA” is intended for use on Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; MES Elecsys and cobas e immunoassay analyzers. buffer 50 mmol/L, pH 6.0; preservative. Note :Please note that the catalogue number appearing on the package insert retains only the first 8 digits of the 11-digit Catalogue number: 06656021190 for b) MES = 2-morpholino-ethane sulfonic acid the Estradiol III. The last 3 digits -190 have been replaced by -119 for logistic Precautions and warnings purposes. For in vitro diagnostic use. Summary Exercise the normal precautions required for handling all laboratory Estrogens are responsible for the development of the secondary female sex reagents. characteristics. Together with gestagens they control all the important female Disposal of all waste material should be in accordance with local guidelines. reproductive processes. Safety data sheet available for professional user on request. The biologically most active estrogen is 17β‑estradiol. This is a steroid hormone This kit contains components classified as follows in accordance with the having a molecular weight of 272 daltons. Regulation (EC) No. 1272/2008: Estrogens are produced primarily in the ovary (follicle, corpus luteum), but small 2-methyl-2H-isothiazol-3-one hydrochloride quantities are also formed in the testes and in the adrenal cortex. During pregnancy, estrogens are mainly formed in the placenta.1 In human plasma the EUH 208 May produce an allergic reaction. bulk of estradiol is bound specifically to SHBG (= sex hormone binding globulin) and non-specifically to human serum albumin.2 Product safety labeling follows EU GHS guidance. Estrogen secretion is biphasic during the menstrual cycle. The determination of For USA: Caution: Federal law restricts this device to sale by or on the estradiol is utilized clinically in the elucidation of fertility disorders in the order of a physician. hypothalamus‑pituitary‑gonad axis, gynecomastia, estrogen‑producing ovarian Avoid foam formation in all reagents and sample types (specimens, and testicular tumors. Further clinical indications are the monitoring of fertility calibrators and controls). therapy and determining the time of ovulation within the framework of in vitro fertilization (IVF).1,3 Reagent handling The Elecsys Estradiol III assay employs a competitive test principle using two The reagents in the kit have been assembled into a ready‑for‑use unit that monoclonal antibodies specifically directed against 17β‑estradiol. Endogenous cannot be separated. estradiol released from the sample by mesterolone competes with the added All information required for correct operation is read in from the respective estradiol derivative labeled with a ruthenium complexa) for the binding sites on reagent barcodes. the biotinylated antibody. a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) ) Storage and stability Store at 2‑8 °C. Test principle Competition principle. Total duration of assay: 18 minutes. Do not freeze. ▪ 1st incubation: By incubating the sample (25 µL) with two Store the Elecsys reagent kit upright in order to ensure complete estradiol‑specific biotinylated antibodies, immunocomplexes are formed, availability of the microparticles during automatic mixing prior to use. the amount of which is dependent upon the analyte concentration in the Stability: sample. ▪ 2nd incubation: After addition of streptavidin-coated microparticles and unopened at 2‑8 °C up to the stated expiration date an estradiol derivative labeled with a ruthenium complex, the still-vacant after opening at 2‑8 °C 12 weeks sites of the biotinylated antibodies become occupied, with formation of an antibody‑hapten complex. The entire complex becomes bound to the on the analyzers 8 weeks solid phase via interaction of biotin and streptavidin. Specimen collection and preparation ▪ The reaction mixture is aspirated into the measuring cell where the Only the specimens listed below were tested and found acceptable. microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with Serum collected using standard sampling tubes or tubes containing ProCell/ProCell M. Application of a voltage to the electrode then induces separating gel. chemiluminescent emission which is measured by a photomultiplier. Li‑heparin, K2‑EDTA and K3‑EDTA plasma as well as plasma separation ▪ Results are determined via a calibration curve which is instrument- tubes. specifically generated by 2‑point calibration and a master curve provided Criterion: Slope 0.9‑1.1 + intercept within < ± 10 pg/mL + coefficient of via the reagent barcode or e‑barcode. correlation ≥ 0.95. Reagents - working solutions For individual samples recovery within 70‑130 % of serum value The reagent rackpack is labeled as E2 III. > 100 pg/mL, recovery of ± 20 pg/mL of serum value ≤ 100 pg/mL. Stable for 24 hours at 20‑25 °C, 2 days at 2‑8 °C, 6 months at M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: -20 °C (± 5 °C). Freeze only once. Streptavidin-coated microparticles 0.72 mg/mL; preservative. The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could 2020-05, V 6.0 Can English 1 / 6 Elecsys Estradiol III affect the test results in some cases. When processing samples in primary exceptional cases the barcode cannot be read, enter the 15-digit sequence tubes (sample collection systems), follow the instructions of the tube of numbers. manufacturer. MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Centrifuge samples containing precipitates and frozen samples before PreClean M solution is necessary. performing the assay. Bring the cooled reagents to approximately 20 °C and place on the reagent Do not use heat‑inactivated samples. disk (20 °C) of the analyzer. Avoid foam formation. The system Do not use samples and controls stabilized with azide. automatically regulates the temperature of the reagents and the opening/closing of the bottles. Ensure the samples, calibrators and controls are at 20‑25 °C prior to measurement. Calibration Due to possible evaporation effects, samples, calibrators and controls on Traceability: This method has been standardized against CRM 6004a via the analyzers should be analyzed/measured within 2 hours. ID‑GC/MS (isotope dilution‑gas chromatography/mass spectrometry).4 Sample stability claims were established by experimental data by the Every Elecsys reagent set has a barcoded label containing specific manufacturer or based on reference literature and only for the information for calibration of the particular reagent lot. The predefined temperatures/time frames as stated in the method sheet. It is the master curve is adapted to the analyzer using the relevant CalSet. responsibility of the individual laboratory to use all available references Calibration frequency: Calibration must be performed once per reagent lot and/or its own studies to determine specific stability criteria for its using fresh reagent (i.e. not more than 24 hours since the reagent kit was laboratory. registered on the analyzer). Materials provided Calibration interval may be extended based on acceptable verification of See “Reagents – working solutions” section for reagents. calibration by the laboratory. Renewed calibration is recommended as follows: Materials required (but not provided) ▪ 06656048190, Estradiol III CalSet, for 4 x 1.0 mL ▪ after 1 month (28 days) when using the same reagent lot ▪ 11731416190, PreciControl Universal, for 4 x 3.0 mL ▪ after 7 days (when using the same reagent kit on the analyzer) ▪ 11731416160, PreciControl Universal, for 4 x 3.0 mL (for USA) ▪ as required: e.g. quality control findings outside the defined limits ▪ 03609987190, Diluent MultiAssay, 2 x 16 mL sample diluent Quality control For quality control, use PreciControl Universal. ▪ General laboratory equipment In addition, other suitable control material can be used. ▪ MODULAR ANALYTICS E170 or cobas e analyzer Controls for the various concentration ranges should be run individually at Additional materials for the cobas e 411 analyzer: least once every 24 hours when the test is in use, once per reagent kit, and ▪ 11662988122, ProCell, 6 x 380 mL system buffer following each calibration. ▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning The control intervals and limits should be adapted to each laboratory’s solution individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if ▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive values fall outside the defined limits. ▪ 11933159001,